Orthodontic Appliance ComplicationALT-RAMECNCT05345756
Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients
A study testing Intraoral protraction device and Extraoral protraction device in people with Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Intraoral protraction device and Extraoral protraction device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or Female Growing Patient ( CVM2-CVM3 )
- Skeletal class III (ANB ≤ 0 , A-NV≤ -2 and wits appraisal < -0.3mm)
- Erupted upper and lower first permanent molars and permanent incisors
- Reverse overjet up to -4 mm
Who cannot join
- History of previous orthodontic treatment
- Cleft lip/palate patients
- Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
- Patients with syndromes
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and dental medicine - Cairo University
Cairo, Manial, 11553
Andrew Wafdy, Bachelor's, +0201272912299, androwafdy@gmail.com
About this study
Official title: Intraoral Maxillary Protraction Technique With ALT-RAMEC ( Alternate Rapid Maxillary Expansion and Constriction) Protocol Versus Facemask With Maxillary Expansion in Treating Class III Growing Patients With Maxillary Deficiency: A Randomized Clinical Trial
The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction
Read the detailed description
Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Intraoral protraction device, Extraoral protraction device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral protraction deviceDevice
Use of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT-RAMEC protocol
Extraoral protraction deviceDevice
Facemask which is an extraoral appliance used for maxillary protraction
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Protraction Technique | Experimental | using intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander Receives: Device: Intraoral protraction device |
| Extraoral Protraction Technique | Active comparator | using facemask for maxillary protraction after ALT-RAMEC protocol Receives: Device: Extraoral protraction device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary skeletal changes
using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA)
Measured: 8 months
Secondary outcomes (2)
Mandibular skeletal changes
using lateral cephalometric x-ray to measure mandibular skeletal changes using angular measurements in degrees (SNB)
Measured: 8 months
Maxillary and Mandibular dental changes
using lateral cephalometric x-ray to measure changes using angular measurements in degrees (U1/Palatal plane ,L1/Mandibular plane)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Wafdy Nan Demian, Cairo University
- Investigators
- Andrew Demian, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345756
- Sponsor's protocol ID
- ASR1
- Acronym
- ALT-RAMEC
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoral Maxillary Protraction Technique With ALT-RAMEC ( Alternate Rapid Maxillary Expansion and Constriction) Protocol Versus Facemask With Maxillary Expansion in Treating Class III Growing Patients With Maxillary Deficiency: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05345756
- Acronym / sponsor ID
- ALT-RAMEC / ASR1
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction
Detailed description
Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoral Protraction Technique | Experimental | Device: Intraoral protraction deviceusing intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander |
| Extraoral Protraction Technique | Active comparator | Device: Extraoral protraction deviceusing facemask for maxillary protraction after ALT-RAMEC protocol |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or Female Growing Patient ( CVM2-CVM3 )
- Skeletal class III (ANB ≤ 0 , A-NV≤ -2 and wits appraisal < -0.3mm)
- Erupted upper and lower first permanent molars and permanent incisors
- Reverse overjet up to -4 mm
Key exclusion criteria (4 listed)
- History of previous orthodontic treatment
- Cleft lip/palate patients
- Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
- Patients with syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral protraction deviceUse of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT-RAMEC protocol | Device | Intraoral Protraction Technique |
| Extraoral protraction deviceFacemask which is an extraoral appliance used for maxillary protraction | Device | Extraoral Protraction Technique |
Primary outcome
Maxillary skeletal changes
Time frame: 8 months
using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA)
2 secondary outcomes
Mandibular skeletal changes
Time frame: 8 months
Maxillary and Mandibular dental changes
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Demian, BDS principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral protraction device and Extraoral protraction device in people with Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Demian, BDS (+0201272912299, androwafdy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary skeletal changes (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.